1717WCE-HS
The 1717WCE-HS is a digital flat-panel X-ray detector for general radiographic imaging of human anatomy. It replaces film or screen-based image capture when integrated with a radiographic…
The 1717WCE-HS is a digital flat-panel X-ray detector for general radiographic imaging of human anatomy. It replaces film or screen-based image capture when integrated with a radiographic system. It is not intended for mammography.
A cesium iodide scintillator is coupled to a thin-film transistor sensor to capture and digitize X-ray exposures. The detector transfers images through wired or wireless communication to the imaging system. A separate console application can process raw data into DICOM-compatible images for diagnosis and analysis.
Detector Format
The HS model has a 17 by 17 inch imaging area and 140-micrometre pixel pitch. Its exterior is white with green markings. An X-ray generator is required separately.
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (4), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| iRay Imaging Technology Taicang Limited | Taicang | Jiangsu | Contract manufacturer | 3 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| iRay Group | Shanghai | Shanghai | Specification developer | 4 |
| Fujifilm Imaging System (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Careray Digital Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Showing 12 of 13. All 13 manufacturers in China registered for Solid State X-Ray Imager (Flat Panel/Digital Imager)
Record
| Listed by | Rayence Co., Ltd., South Korea |
|---|---|
| FDA product code | MQB |
| Device type | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Manufacturer |
| 510(k) | K242394 |
| Record published | 2024-09-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1717WCE-HS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sedecal | Sedecal., Sa. | 70 |
| Schick33 | Sirona Dental, Inc. | 44 |
| Drgem | Drgem Corporation | 41 |
| Schick | Dentsply LLC | 35 |
| Wireless Digital Flat Panel Detector | iRay Group | 27 |
| Fuji IP Cassette CC | Fujifilm Corporation | 20 |
| Canon Inc. | Canon Inc. | 20 |
| Fona Stellaris | Sirona Dental, Inc. | 20 |
| Exprimer | Drtech Corporation | 18 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | Samsung Electronics Co., Ltd. | 17 |
| X-ray Flat Panel Detector | Careray Digital Medical Technology Co., Ltd. | 16 |
| Regius Cassette | Konica Minolta, Inc. | 16 |
Showing 12 of 509. All products under Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253800 | 2026-07-31 |
| K242394 | 2024-09-09 |
| K240371 | 2024-03-07 |
| K231467 | 2023-06-21 |
| K212753 | 2021-10-18 |
| K210985 | 2021-04-28 |
| K202722 | 2020-10-26 |
| K201796 | 2020-07-23 |
| K171418 | 2017-06-12 |
| K171417 | 2017-06-12 |
| K171420 | 2017-06-09 |
| K171419 | 2017-06-09 |
| K162519 | 2016-10-06 |
| K162518 | 2016-10-06 |
| K150150 | 2015-03-27 |
| K141566 | 2014-07-16 |
| K141563 | 2014-07-16 |
| K140056 | 2014-05-13 |
| K140060 | 2014-05-13 |
| K140646 | 2014-04-11 |
| K133409 | 2014-02-21 |
| K131114 | 2013-09-17 |
| K130935 | 2013-07-02 |
| K123345 | 2013-03-12 |
| K122928 | 2013-01-30 |
| K122919 | 2013-01-01 |
| K122173 | 2012-10-19 |
| K122182 | 2012-08-16 |
| K113630 | 2011-12-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.